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Trichomonas Vaginalis TV RT PCR Detection Kit Operation Manual 48 Tests/Kit

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Trichomonas Vaginalis TV RT PCR Detection Kit Operation Manual 48 Tests/Kit

City & Province	guangzhou

Product Details

Trichomonas vaginalis (TV) RT-PCR Detection Kit (Lyophilized) Operation Manual

--48 tests/kit

Intended use:

By using real time PCR systems, Trichomonas vaginalis (TV) real time PCR kit is used for the in vitro qualitative detection of TV. It can be used for the laboratory diagnosis and monitoring of TV infection. The test results are only for clinical reference, not for case confirmation or exclusion.

Principle:

The specific primers and specific fluorescent probes are designed for the nucleic acid conserved region of Trichomonas vaginalis (TV). The RT-PCR reaction solution and real-time fluorescent quantitative PCR detection technology is applied on the fluorescence quantitative PCR instrument for realizes the rapid detection of TV through the change of fluorescence signal. The detection system contains a human internal control (IC) gene, which is used to monitor whether the specimens and the process of nucleic acid extraction is qualified.

TV product lyophilization pacakage:

Main components:

No.	Components	BIK-QL-H0020S
1	PCR Enzyme Mix(Lyophilized)	48 tests/kit
2	Positive Control	100 μL/tube
3	Negative Control	100 μL/tube
4	RNase-free water	1mL/tube
5	Paraffin oil	1.5mL/tube

Note: Do not mix the components from different batches for detection. The Positive Control of TV and internal control were constructed artificially, and they were not infectious.

Specimen requirements:

1. Specimen type

Urine or female vaginal secretions swab samples.

2. Specimen Preservation

The specimen can be stored for 3 months at -20±5℃ and for a long time below -70℃

PCR Amplification condition:

PCR amplification according to the following procedures:

Step	Cycle number	Temperature	Time
1	1	95℃	3min
2	40	95℃	10s
2	40	60℃	30s collect fluorescent

Instrument detection channel selection: FAM and HEX/VIC.

Quality control:

	Ct value
Negative Control	No Ct
Positive Control	≤30
IC of samples	≤38

Note: Negative Control, Positive Control and IC of samples must be performed correctly, otherwise the sample results is invalid.

Performance indexes of product:

Accuracy:Use national reference products or enterprise positive/negative reference products for testing, and the results are all positive/negative.
Detection limitation:1000 copies/mL.
Precision: The coefficient of variation (CV) of Ct values is≤5%.
Specificity: The detection results of this kit have no cross reaction with Urealytic Mycoplasma, Mycoplasma hominis, Ureaplasma urealyticum, Mycoplasma pneumoniae,Neisseria gonorrhoeae,Chlamydia trachomatis,herpes simplex virus type Ⅱ,Mycoplasma genitalium.

Operation details please check from IFU!